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U.S. Department of Health and Human Services

Class 2 Device Recall Curlin

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 Class 2 Recall
Curlin
see related information
Date Posted August 07, 2007
Recall Status1 Terminated on May 28, 2008
Recall Number Z-1129-2007
Recall Event ID 38341
Premarket Notification
510(K) Number
K981816 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
Code Information Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716
Recalling Firm/
Manufacturer
Curlin Medical Llc
15751 Graham St
Huntington Beach, California 92649-1630
For Additional Information Contact Marc Drobnack
714-893-2200 Ext. 141
Manufacturer Reason
for Recall
The Administration Sets may leak at the reservior bag.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels. A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels.
Quantity in Commerce 25, 280
Distribution One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BECTON DICKINSON CURLIN, LLC.
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